CompoSeal Mobilea II Operating Instructions Ver 3 Sept 2014

EN

OPERATING INSTRUCTIONS

1 1.1 1.2

Basic information... EN-1 Intended use... EN-1 Function... EN-1

2 2.1 2.2 2.3 2.4

Safety... EN-1 General instructions... EN-1 Power pack...EN-2 Operating the system...EN-2 Categories used for safety instructions...EN-2

3 3.1 3.2 3.3

Scope of delivery...EN-2 Storage... EN-4 Transportation... EN-4 Packaging... EN-4

4 4.1 4.2 4.3 4.4

Operation... EN-4 Preparing the power supply unit... EN-4 Charging the powerpack... EN-4 Tube sealing... EN-5 Cleaning the system... EN-6

5 5.1 5.2 5.3 5.4

Maintenance...EN-7 Power pack care...EN-7 Taking the hand sealer apart...EN-7 Cleaning the parts... EN-8 Reassembling the hand sealer... EN-8

6 6.1 6.2 6.3

Specifications... EN-9 Ordering information... EN-9 System classification... EN-10 Type labels... EN-10

7 Disposal... EN-11 7.1 By the manufacturer... EN-11 7.2 By the operator... EN-11 8

Troubleshooting... EN-11

9

Declaration of Conformity... EN-12

EN

1 Basic information

1 BASIC INFORMATION These Operating Instructions form part of the system CompoSeal Mobilea II: they contain information that is necessary to use it safely. Read these Instructions before starting to use the equipment. Revision history Version 3.0: September 2014, redesign Copyright (c) 2010-2014 Fresenius Kabi AG All rights reserved

1.1 Intended use The CompoSeal Mobilea II can be used to seal medical PVC tubing (termed "tube" or "tubing" from now on) hermetically and create a break-off point. The exterior diameter must be between 3 and 4.6 mm; wall thickness must not exceed 0.8 mm. Tubing may be filled with air, a 0.9 % NaCl solution, blood or blood components. The system's fields of application range from blood donation and processing to blood storage. The system is mobile and its sealing features can also be used on tubing attached to a donor. Do not use the equipment for any purpose not described in this document.

1.2 Function When you place a tube between the electrodes and activate the hand sealer, radiofrequency energy is transmitted to the electrodes and the plastic is melted to form a sealing seam. You can then separate the tube at this sealing seam.

2 SAFETY !

EN

CAUTION

Observe the safety instructions! This avoids damage to property and personal injury. Do not start using the system until you have been instructed in its use by the manufacturer or the person responsible for the system. • Read these Operating Instructions before starting to use the equipment. • Make sure that the system is operational and that none of its components are damaged. • Assembly, extensions, adjustments, modifications or repairs may only be carried out by the manufacturer or persons authorised by the manufacturer.

2.1 General instructions • Always keep the Operating Instructions near the system for reference. • Include the Operating Instructions if you give the product to someone else. • Observe the accident prevention regulations. • The system may be operated, used and serviced only by specialist personnel: such personnel are persons possessing specialist training, knowledge and experience, enabling them to understand and assess the work they are assigned and identify any potential dangers. • Ensure that your working area has good lighting.

EN-1

3 Scope of delivery

2.2 Power pack Stop and turn off the power pack if it becomes unusually hot or starts producing noises or odors. Inform the Service Team. Protect the power pack from moisture and humidity, and from fire and heat. Do not open its casing and do not create any short circuits. The power pack contains rechargeable lithium-ion batteries. If used improperly, lithium-ion batteries can release poisonous or acrid substances or can even catch fire. Dispose of batteries that are no longer useable in the proper way and in accordance with legal requirements.  7 Disposal, Page EN-11

2.3 Operating the system • Operate the system for its intended use only. • Observe national regulations for connecting the system to mains power. • Take technical data into account. • Only use parts supplied with the system or original spare parts. • Do not connect up any other equipment or cables. • Do not use the system in connection with flammable preparations. • Make sure that no part of the system is damaged in any way. • Avoid bringing any part into contact with fluids – this could cause system malfunctions.

2.4 Categories used for safety instructions The meaning of the various safety instructions given is as follows: !

CAUTION

Indicates a situation where damage or injury may occur. If not avoided, the situation may result in light damage or minor injuries.

NOTE Indicates that there is a danger of reduced quality in the work produced or that material damage may occur to equipment.

3 SCOPE OF DELIVERY A

B C D E

D

F

A RF cable D Power adapter B Operating Instructions E Power pack and accompanying F Power supply documents unit C Hand Sealer

EN-2

3 Scope of delivery Power pack

Hand Sealer

EN

G

L J K M

H I G RF cable connection H Power indicator (yellow) I Charging and sealing indicator (green)

J Sealing indicator K Electrodes

The power pack is a mobile power storage device that supplies the power needed for sealing. The indicators and audible alarm indicate the status of the power pack or sealing operation.

The electrodes are located on the hand sealer. They are moved using a spring mechanism. The process involves inserting a tube, which is then pressed together and sealed. The sealing indicator (J) is illuminated during the sealing operation.

NOTE Lithium-ion batteries reach full capacity only after several charge cycles. When fully charged, the battery has sufficient capacity to power more than 1,000 sealing operations under ideal conditions. Although lithium-ion batteries age much more slowly than is the case for e.g. NiCD batteries, the battery will lose some capacity over time. If battery capacity falls below 600 sealing operations per charge, we recommend that the battery is replaced by a service technician authorized by the manufacturer.

L RF cable M Handle and mechanism

RF cable The RF cable transmits power from the power pack to the hand sealer. Power supply unit and adapter

F

D D Power adapter F Power supply unit

EN-3

4 Operation The adapters are used to adjust the power supply unit to fit the country-specific mains supply (wall outlet). The power supply unit cable is used to charge the power pack. Operating Instructions The printed Operating Instructions can be found behind the carry case lining. Carry case The carry case provides secure transport and storage for the system components. Any adapters not required should be kept in the case.

3.1 Storage

4 OPERATION Initial start-up must be performed by a member of Fresenius Kabi's Technical Service team or a person authorized by this team.

4.1 Preparing the power supply unit NOTE Only use the power supply unit to charge Mobilea II power packs. The reverse is true: only charge Mobilea II power packs using the power supply unit provided.

Store the system in a well-ventilated room whose temperature stays generally constant. Store the hand sealer, power pack and power supply unit from -20 °C to +50 °C and for max. 6 months.

1 Select an appropriate adapter for your wall outlet (D). This is only required once, during initial start-up. 2 Push the adapter onto the power supply unit (F) until it snaps home.

NOTE

4.2 Charging the powerpack

If a power pack is stored for longer or at a higher temperature than stated, this can lead to total discharge and thus damage the unit. • Give the power pack a full charge at least once every six months.

NOTE Make sure that the temperature of the power pack is kept between +10 °C and +40 °C. If required, wait an hour or so until the system has adjusted itself to the ambient temperature.

3.2 Transportation Always transport the system in its original carry case.

3.3 Packaging Remove the parts needed from the transport packaging and save the packaging for future transportation.

EN-4

Give the power pack a full charge before using it for the first time. The charging process can take up to two hours. 1 Place the power pack on your work surface. 2 Connect the power supply unit to the wall outlet. 3 Plug the charging cable (N) into the charging socket on the (O) power pack.

4 Operation

4.3 Tube sealing N

O

N Charging cable

O Charging socket

The charging process starts automatically. 4 Check the power indicator (H) and the charge/seal indicator (I).

EN

1 Remove the charging cable from the power pack. Sealing is only possible with the cable disconnected. 2 Plug the RF cable (A) into the ports on the hand sealer (L) and the power pack (G). Turn the locks clockwise to secure them in place. 3 Place the tube to be sealed (P) between the hand sealer's sealing electrodes (K) – ensure a proper fit as shown in the picture. Tubing must be clean, dry and free from grease. Maintain a distance of at least 30 cm to a connected patient.

J

K P

J Sealing indicator K Electrodes I H H Power indicator (yellow) I Charging and sealing indicator (green) INDICATOR Yellow (H) illuminated

DESCRIPTION Power pack is charging Yellow (H) illuminated + Power pack is green (I) flashing charged

P Tubing

INDICATOR DESCRIPTION Green illumiSealing in progress nated (3 s) Green illumiSealer opened too early, nated (3 s) + sealing seam not tight. beep Green + yellow Power pack can power a illuminated + max. of 30 more sealing beep operations Green illumiSealing not possible. nated + beep Power pack is empty/has overheated or tube not present

EN-5

4 Operation !

CAUTION

Danger of injury with hand sealer! • Electrodes carry a voltage during the sealing process. Do not touch the electrodes! • Do not place electrically conductive material between the electrodes during the sealing operation. • Do not trap fingers while closing the hand sealer. • Long periods of sealing can lead to repetitive strain injury symptoms for the operator. Danger of sparking! • Sparks can be created during the sealing process. Keep flammable substances at a distance. Danger of injury from fluids! • Do not pull the tubing apart during a sealing operation – this could cause fluid leakage. Leaking fluids (e. g. blood) can harm the operator and may also soil or damage the system. Danger of injury or soiling from fluids! • Do not let the system come into contact with any fluids. • After each sealing operation, check the seam for fluid leakage. 4 Press the hand sealer firmly to close it until the sealing indicator (J) is illuminated; keep the hand sealer closed. The sealing indicator is illuminated during sealing. 5 Keep the sealer closed for approx. 2 seconds longer after the sealing indicator (J) goes off. The tube is then sealed. 6 Remove the tube. 7 Check the seam for any fluid leakage. 8 If the sealing seam is not tight, then repeat the sealing operation approx. 1 cm to the right or left of the non-tight seam. 9 Separate the tubing at the sealing seam. To do so, simply pull the tubing apart.

EN-6

NOTE The Mobilea II can perform up to 30 sequential sealing operations. Let the power pack cool down for a few seconds after each sealing operation. Errors during sealing The hand sealer emits a warning beep to indicate the sealing operation was defective (e. g. because of soiled tubing). If this happens, repeat the sealing operation at a clean place on the tube. Power pack almost empty With a fully-charged power pack, you can perform over 1,000 sealing operations under ideal conditions. Once the remaining power is sufficient only for 15–30 sealing operations, the power pack emits a warning beep during each operation and the indicators are illuminated.  4.2 Charging the powerpack, Page EN-4

4.4 Cleaning the system NOTE As a general rule, use only non-corrosive, non-aggressive alcohol-based surface disinfectants (e. g. Frekanol). Disinfect by wiping only: do not use spray or steam disinfection! Electrodes Contamination of the hand sealer may seriously impair the sealing quality. If the sealer electrodes are contaminated by fluid, sparks may occur and lead to poorquality seals. Remove any soiling immediately. 1 Unplug the RF cable from the hand sealer: To do so, release the lock on the RF cable by turning it anti-clockwise.

5 Maintenance 2 Clean the electrodes and the surrounding area with a cotton bud soaked with the cleanser. 3 Dry all cleaned surfaces using another cotton bud. Continue sealing only if the surfaces are clean and dry. If you cannot remove the contamination, then take the hand sealer apart for cleaning.  5.2 Taking the hand sealer apart, Page EN-7 Power pack Remove any soiling immediately. 1 Unplug the RF cable from the power pack. To do so, release the lock on the RF cable by turning it anti-clockwise. 2 Apply a suitable cleaning agent to a soft cloth. Use this cloth to clean the power pack. 3 Make sure the power pack is dry before it is reconnected.

5 MAINTENANCE Perform maintenance work regularly. We recommend signing a maintenance agreement: this ensures optimum product lifetime and means you can avoid potentially expensive repairs.

5.1 Power pack care

2 Hold the hand sealer as shown in the following picture.

Q

R

S

Q Sealing head S Handle R Non-movable part 3 Use your middle finger to press the moveable sealing head (Q) downwards. Provide resistance by holding the nonmovable part (R) with your thumbs. 4 Slide the handle (S) forwards and then downwards. This will disengage the handle. 5 Use your thumbs to push the sealing head upwards. If needed, provide resistance with your index finger on the nonmovable part (R).

Q

R

Improper handling will reduce the capacity and the service life of the battery. Charge the power pack regularly. Note – for longer periods of storage:  3.1 Storage, Page EN-4

5.2 Taking the hand sealer apart 1 Unplug the RF cable from the hand sealer: to do so, release the lock on the RF cable by turning it anti-clockwise.

6 Tilt the head forwards and then pull it off.

EN-7

EN

5 Maintenance

T

1 Before reassembly, lightly grease the following parts with Vaseline: • Leaf spring near the bolt • Interior of the sealing head (guide surfaces) • Bar in the handle • Guide parts of the hand sealer housing 2 Place the handle (S) on the non-movable part (R) from below. Q R

T Leaf spring 7 Pull the leaf springs (T) out and then remove the handle.

5.3 Cleaning the parts

T

1 Clean off contamination on the individual parts using a cloth or cotton bud soaked in a suitable cleanser.  4.4 Cleaning the system, Page EN-6 2 Dry all cleaned surfaces using a cloth or a new cotton bud. Once all surfaces are clean and dry, you can start putting the hand sealer back together.

Q Sealing head S Handle R Non-movable part T Leaf spring

5.4 Reassembling the hand sealer NOTE On assembling the components make sure you do not mix up the components for one hand sealer with the components for another sealer.

EN-8

S

3 Slide the leaf springs (T) completely inside the handle from the front. 4 Put the sealing head (Q) in position. 5 Slide the handle (S) in until it snaps into place. 6 Check the hand sealer: to do so, activate the handle a few times. 7 Plug the RF cable into the hand sealer and the power pack. Turn the RF cable locks clockwise to secure them in place. The CompoSeal Mobilea II is now operational again.

6 Specifications

6 SPECIFICATIONS FEATURE

EN POWER PACK

Height Width Depth

HAND SEALER 215 mm 65 mm 30 mm

Weight

315 g

760 g

POWER SUPPLY UNIT (PSU) 130 mm 65 mm 75 mm (incl. Euro adapter) 270 g

Housing material

Aluminium

Aluminium

PC/ABS

FEATURE Voltage supply Power pack performance data Operating mode Capacity Operating conditions during sealing Storage conditions

145 mm 110 mm 52 mm

CARRYING CASE 395 mm 295 mm 106 mm 900 g (without system) PP/PUR

DESCRIPTION 100–240 V AC, 50–60 Hz, 700 mA input, secondary 18 V DC, 1.66 A Lithium-polymer rech. battery, battery capacity: 2000 mAh, voltage: 14,8 V, radio-frequency output: 60 watts at 50 ohms, 40.69 MHz, power consumption: 40 watts Intermittent operation, up to 30 sealing operations possible in quick succession At least 1,000 sealing operations possible under ideal conditions with a fully-charged power pack Temperature: +10 to +35 °C Relative humidity: 30–75 %, atmospheric pressure 700– 1060 hPa Temperature: -20 °C to +50 °C max. 6 months Relative humidity: 30–75 %, atmospheric pressure 500– 1060 hPa

6.1 Ordering information PART NUMBER 902 701 1

DESCRIPTION CompoSeal Mobilea II Set

SPARE PART NUMBER 902 700 1 902 702 1 902 703 1 902 704 1 902 705 1 M69 374 1

DESCRIPTION CompoSeal Mobilea II Power pack CompoSeal Mobilea II Hand sealer CompoSeal Mobilea II Power supply unit CompoSeal Mobilea II RF cable CompoSeal Mobilea II Carry case CompoSeal Mobilea II Operating instructions

EN-9

6 Specifications

6.2 System classification Classification to 93/42/EEC CompoSeal Mobilea II is a medical device, classified as Class I equipment according to EC Directive 93/42/EEC, Annex IX, Rule 12. Electrical safety classification to DIN EN 60601-1, IEC 601-1, VDE 0750 HAND SEALER POWER PACK POWER SUPPLY UNIT (PSU) Class II Type CF Type CF IP 21 IP 21 IP 40 The CompoSeal Mobilea II is EMC-compatible to DIN EN 60601-1-2. For further information, please refer to the accompanying document behind the carry case lining.

Protection against electric shock Applied part Protection type Electromagnetic compatibility

6.3 Type labels Power pack

SYMBOL

DESCRIPTION Device emits non-ionising radiation.

E-code

Equipment code for the system. The system complies with the requirements of the MDD (Medical Device Directive/Medizinproduktegesetz). Weight of device

U

U Bar code optional The system is UL-approved SYMBOL

IP

DESCRIPTION Applied part (Type CF) Protection type The system must not be disposed of in household waste. Class II Radio frequency oscillator

EN-10

Li-ion

Lithium-ion rechargeable battery

7 Disposal

7 DISPOSAL

8 TROUBLESHOOTING

Valuable natural resources were used in the manufacture of the CompoSeal Mobilea II, and these can be recycled.

The hand sealer does not function correctly 1 Check the charge status of the power pack. 2 Connect a different hand sealer to the power pack and try to seal a piece of tubing. 3 Charge the power pack as needed.

7.1 By the manufacturer Within the EU, the manufacturer will take back the system for disposal. For further information about returning the system, contact Customer Service (see the address on the back of these Operating Instructions).

7.2 By the operator You must comply with statutory regulations if you dispose of the system yourself. Before disposal, ensure the system is disinfected professionally.

EN

Power pack does not charge 1 Check the connection to the power supply unit. The yellow indicator must be illuminated. 2 If the indicator is not illuminated: check the power supply unit, wall outlet and cable. 3 Charge the power pack again as needed.

NOTE !

CAUTION

Environmental hazard if disposed of incorrectly! Observe local statutory provisions for the disposal of lithium-ion batteries and electronic devices. • If necessary, contact the manufacturer's service department.

In all other cases, or if problems occur again, please contact your nearest authorized CompoSeal Service team. The Service team will ensure that your problem is diagnosed and resolved rapidly and professionally.

EN-11

9 Declaration of Conformity

9 DECLARATION OF CONFORMITY

EN-12

Notes Notes

EN

EN-13

M69 374 1 • 2014-09-03

CompoSeal Mobilea II

Fresenius Kabi AG 61346 Bad Homburg GERMANY Phone: ++49 (0) 61 72 / 608–0 www.fresenius-kabi.de